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Pink Sheet – US FDA Biologics Group Emerging From Pandemic Footing – But Not Vaccines

Pink Sheet – US FDA Biologics Group Emerging From Pandemic Footing – But Not Vaccines

The US Food & Drug Administration’s vaccine review operations are still not close to returning to pre-pandemic levels of operations, Center for Biologics Evaluation & Research Director Peter Marks said during a Reagan-Udall Foundation/Friends of Cancer Research event.

“In the area of vaccines, we are still very much under a very large load of work,” Marks said. “Vaccines are not in any way shape or form [back to] routine, every day” status. “So, it is not over yet from the standpoint of the pandemic in the vaccines arena.”

Marks provided the update during a panel discussion as part of a “close-out” meeting for the RUF/Friends of Cancer Research “Evidence Accelerator” collaboration on 20 October. The project was initiated to help support FDA and product developers in applying real world data to COVID projects. (Also see “US FDA Looking To Real-World Evidence To Fill in Gaps On COVID-19 Vaccines” – Pink Sheet, 11 Jun, 2020.)

The vaccines group remains under pressure from three distinct streams of work:

  • Converting COVID vaccines from “Emergency Use” to full approval status;

  • Preparing for a new wave of COVID vaccines; and

  • Catching up on other vaccines whose development was delayed by COVID.

While CBER’s therapeutics workload from COVID is diminishing, the work on the vaccines side is continuing. Rather than overseeing EUA projects that were largely abandoned, the vaccines group has a “cohort” of successful vaccines “that we have to bring forward to licensing.”

In addition, “we have new vaccines coming along in the COVID-19 space and … depending on what happens with action from Congress and funding” there are “manufacturers thinking about developing a whole new wave of COVID-19 vaccines.” Marks said. So, there is still “lots going on there.”

But the vaccines office in CBER also has a surging workload in non-COVID projects, Marks added. (See sidebar for a story on some of the more prominent vaccines.)

“Over the past few years, there has been a collection of submissions of non-COVID vaccines that have been kind of held back” given the urgency of the pandemic, Marks said. Now “that are all coming along down the pike together.”

The impact of COVID is also straining the vaccine surveillance functions at CBER, Marks added. “Our surveillance mechanisms for safety and effectiveness for the vaccines that were deployed, and now the boosters that were deployed – just that work on top of our routine surveillance has put a tremendous amount of workload on our biostats and epidemiology offices.”

CBER has taken one important action to help prepare to address the strains on the vaccine group: naming a new director for the Office of Vaccines Research & Review (David Kaslow) after a prolonged period with Marks serving as acting director. (Also see “US FDA ‘Actively Working’ To Fill Vaccine Leadership Positions Ahead Of Next Round Of COVID Reviews” – Pink Sheet, 23 Mar, 2022.)

CBER’s review activities in cell/gene therapies and blood products, on the other hand, “are starting to get back to more normal situations,” Marks said. (Also see “CBER’s Goal To Reach Normal Ops In 2023 Includes Clearing IND, Meeting Backlogs In 2022” – Pink Sheet, 11 Jul, 2022.)

“Certain areas have gotten back towards normal,” he said. “Cell and gene therapies, blood products, have been able to get back on target and things are moving.” In those areas, “many of the things that were under EUA ultimately went away because they didn’t work or because no one wanted to take them further.”

The “return to normal” for the cell and gene therapy group, however, has to be taken in the broader context of a planned rapid expansion and reorganization to accommodate the burgeoning pipeline of commercial and academic projects in the field. (Also see “New Name, Old Problems: US FDA’s Cell And Gene Therapy Office Still Facing Growth Challenges” – Pink Sheet, 5 Oct, 2022.)–But-Not-Vaccines